Skip to main content
OpenTrials
Completed

NCT Number: NCT01623531

Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery

The aim of the study is to show that first line treatment with concentrated fibrinogen has superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Complication During Procedure Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CapitalDHACanada

Halifax, Nova Scotia, B3H3A7, Canada

About this study

All patients will be recruited from the Queen Elizabeth II (QEII) Health Sciences Center, Halifax, Nova Scotia, which is the sole tertiary cardiac surgical referral center in Nova Scotia that performs approximately 1000 open heart surgical procedures yearly, including more than 700 isolated coronary artery bypass graft (CABG) procedures.

Inclusion criteria

All patients who are scheduled for elective complex cardiac surgical procedures including, double procedures (aortic valve replacement+coronary artery bypass graft , mitral valve replacement+coronary artery bypass graft , aortic valve replacement+mitral valve replacement), redo-sternotomies, and aortic root repair +/-aortic valve replacement.

Exclusion criteria

Any known congenital or preexisting bleeding disorder, preexisting clinically significant abnormal fibrinogen level, severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l), inability of providing informed consent, emergency surgery, pregnancy or nursing, age under 18 years, intake of anti-platelet drugs within the last 2- 5 days before surgery (low dose aspirin is allowed) allergy to concentrated fibrinogen or other components in the product, anemia (Hb < 110), diagnosed deep venous thrombosis, pulmonary embolism, acute stroke or acute myocardial infarction.

The primary outcome: Cumulative perioperative amount (number of units and total volume) of blood components used between the start of surgery and 24 hours after administration of the study drug or placebo. 'Blood Components' are defined as all fresh components of blood (RBCs, plasma, platelets, and Cryo).

The secondary outcomes: Fibrinogen levels, hematocrit, prothrombin time (PT), partial prothrombin time (PTT), INR, platelet count, Hemoglobin (Hb), Thromboelastometry (ROTEM®, clotting time (CT), clot formation time (CFT), Angle, maximum clot firmness (MCF), Cardiovascular intensive care unit (CVICU-stay), Hospital-stay, In-Hospital Mortality, Hemoglobin, adverse events (anaphylaxis, stroke, myocardial infarction, pulmonary embolism, and deep vein thromboembolism) and usage of factor VII concentrate and human prothrombin complex (factors II, VII,IX, X), total avoidance of transfusion after cardiopulmonary bypass (CPB) 24h after administration of study drug or placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients who are scheduled for elective complex cardiac surgical procedures including

  • double procedures (aortic valve replacement (AVR)+CABG, mitral valve repair/replacement (MVR)+CABG, AVR+MVR)
  • Redo-sternotomies
  • Aortic root repair +/- AVR

Exclusion criteria

  • Any known congenital or pre-existing bleeding disorder
  • pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l)
  • severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l)
  • inability to provide informed consent
  • emergency surgery
  • pregnancy or nursing
  • age under 18 years
  • intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed)
  • allergy to concentrated fibrinogen or other components in the product
  • anemia (Hgb < 110)
  • diagnosed deep vein thrombosis (DVT)
  • pulmonary embolism
  • acute stroke
  • acute myocardial infarction

Treatment and study plan

Fibrinogen

Drug

Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)

Other names: RiaSTAP or Haemocomplettan P

Primary outcomes

  1. Cumulative Transfusion Units

    Time frame: 24 hours after administration of study drug

    Including packed red cells, frozen plasma, platelets, cryoprecipitates

Secondary outcomes

  1. Fibrinogen Plasma Concentration (g/L)

    Time frame: 24h after infusion of study drug

  2. Hematocrit (%)

    Time frame: 24h after infusion of study drug

  3. Hemoglobin Concentration (g/L)

    Time frame: 24h after infusion of study drug

  4. Platelet Count (10^3/μL)

    Time frame: 24h after infusion of study drug

  5. Partial Thromboplastin Time (s)

    Time frame: 24h after infusion of study drug

  6. International Normalized Ratio

    Time frame: 24h after infusion of study drug

    International normalized ratio (INR) is calculated based on the prothrombin time (PT) test results.The PT is usually measured in seconds and is compared to a normal range that reflects PT values in healthy individuals. Because the reagents used to perform the PT test vary from one laboratory to another and even within the same laboratory over time, the normal ranges also will fluctuate. To standardize results across different laboratories in the world, a World Health Organization (WHO) committee developed and recommended the use of the Internationalized Normalized Ratio (INR). The INR is calculated with the ratio of the patient's prothrombin time (PT test) to a normal prothrombin time (control) sample (PT normal): INR=PT test:PT normal. The normal range is from 0.9 to 1.2. The higher the value the more is the patient anticoagulated. This means the patient's blood is thinner with a lower concentration of coagulation factors.

  7. Prothrombin Time (s)

    Time frame: 24h after infusion of study drug

    The prothrombin time (PT) test evaluates how well all of the coagulation factors in the extrinsic and common pathways of the coagulation cascade work together. Included are: factors I (Fibrinogen), II (Prothrombin), V, VII and X.

  8. EXTEM Clotting Time (s)

    Time frame: 24h after infusion of study drug

    EXTEM = rotational thrombelastometry (measurement of extrinsic coagulation pathway); clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation).

  9. EXTEM Maximum Clot Firmness (mm)

    Time frame: 24h after infusion of study drug

    EXTEM = rotational thrombelastometry (measurement of extrinsic coagulation pathway); maximum clot firmness: increasing stabilisation of the clot by the polymerised fibrin, platelets as well as factor XIII.

  10. INTEM Clotting Time (s)

    Time frame: 24h after infusion of study drug

    INTEM = rotational thrombelastometry (measurement of intrinsic coagulation pathway); clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation).

  11. INTEM Maximum Clot Firmness (mm)

    Time frame: 24h after infusion of study drug

    INTEM = rotational thrombelastometry (measurement of intrinsic coagulation pathway); maximum clot firmness: increasing stabilisation of the clot by the polymerised fibrin, platelets as well as factor XIII.

  12. FIBTEM Clotting Time (s)

    Time frame: 24h after infusion of study drug

    FIBTEM = rotational thrombelastometry (measurement of functional fibrinogen); clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation).

  13. FIBTEM MCF (Maximum Clot Firmness)

    Time frame: 24 hours after study drug administration

    Rotational thrombelastometry (measurement of functional fibrinogen). Rotational thrombelastometry (ROTEM) is a point-of-care viscoelastic coagulation test. The device provides four channels for simultaneous assays. With the so called "FIBTEM" assay coagulation is activated by a small amount of tissue thromboplastin (tissue factor) and platelets are blocked with cytochalasin D. The resulting clot is therefore only depending on fibrin formation and fibrin polymerisation. The maximum clot firmness (MCF) is the amplitude in mm on the result graph representing the increasing stabilisation of the clot.

  14. HEPTEM Clotting Time (s)

    Time frame: 24h after infusion of study drug

    HEPTEM = rotational thrombelastometry (measurement of INTEM with heparinase);clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation).

  15. HEPTEM Maximum Clot Firmness (mm)

    Time frame: 24h after infusion of study drug

    HEPTEM = rotational thrombelastometry (measurement of INTEM with heparinase); maximum clot firmness: increasing stabilisation of the clot by the polymerised fibrin, platelets as well as factor XIII.

  16. Total Avoidance of Transfusions

    Time frame: 24h after infusion of study drug

    Total avoidance of any transfusion after cardiopulmonary bypass (CPB) 24h after administration of study drug or placebo.

Other outcomes

  1. Overall Numbers of Patients Receiving Blood Products

    Time frame: 24 hours after administration of study drug

    Including Packed Red Cells, Fresh Frozen Plasma, Platelets, Cryoprecipitate and coagulation factor concentrates. The study was not sufficiently powered to test differences between this outcome.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

The Use of Fibrinogen Concentrate in High-Risk Cardiac Surgery. A Prospective, Double-blinded, Randomized, Controlled Study

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2012
Registry last updated
May 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.